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    Chemistry

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    Also known as: 25332-39-2, Trazodone hcl, Desyrel, Bimaran, Molipaxin, Thombran
    Molecular Formula
    C19H23Cl2N5O
    Molecular Weight
    408.3  g/mol
    InChI Key
    OHHDIOKRWWOXMT-UHFFFAOYSA-N
    FDA UNII
    6E8ZO8LRNM
    Trazodone Hydrochloride
    A serotonin uptake inhibitor that is used as an antidepressive agent. It has been shown to be effective in patients with major depressive disorders and other subsets of depressive disorders. It is generally more useful in depressive disorders associated with insomnia and anxiety. This drug does not aggravate psychotic symptoms in patients with schizophrenia or schizoaffective disorders. (From AMA Drug Evaluations Annual, 1994, p309)
    1 2D Structure

    Trazodone Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-[3-[4-(3-chlorophenyl)piperazin-1-yl]propyl]-[1,2,4]triazolo[4,3-a]pyridin-3-one;hydrochloride
    2.1.2 InChI
    InChI=1S/C19H22ClN5O.ClH/c20-16-5-3-6-17(15-16)23-13-11-22(12-14-23)8-4-10-25-19(26)24-9-2-1-7-18(24)21-25;/h1-3,5-7,9,15H,4,8,10-14H2;1H
    2.1.3 InChI Key
    OHHDIOKRWWOXMT-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    C1CN(CCN1CCCN2C(=O)N3C=CC=CC3=N2)C4=CC(=CC=C4)Cl.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    6E8ZO8LRNM
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Af 1161

    2. Af-1161

    3. Af1161

    4. Apo Trazodone

    5. Apo-trazodone

    6. Deprax

    7. Desyrel

    8. Gen Trazodone

    9. Gen-trazodone

    10. Molipaxin

    11. Novo Trazodone

    12. Novo-trazodone

    13. Nu Trazodone

    14. Nu-trazodone

    15. Pms Trazodone

    16. Pms-trazodone

    17. Ratio Trazodone

    18. Ratio-trazodone

    19. Ratiotrazodone

    20. Thombran

    21. Tradozone

    22. Trazodon Hexal

    23. Trazodon Neuraxpharm

    24. Trazodon-neuraxpharm

    25. Trazodone

    26. Trazodonneuraxpharm

    27. Trazon

    28. Trittico

    2.3.2 Depositor-Supplied Synonyms

    1. 25332-39-2

    2. Trazodone Hcl

    3. Desyrel

    4. Bimaran

    5. Molipaxin

    6. Thombran

    7. Trazodone (hydrochloride)

    8. Af-1161

    9. Trialodine

    10. Kb-831

    11. Oleptro

    12. 19666-36-5

    13. 6e8zo8lrnm

    14. 2-(3-(4-(3-chlorophenyl)piperazin-1-yl)propyl)-[1,2,4]triazolo[4,3-a]pyridin-3(2h)-one Hydrochloride

    15. Nsc-292811

    16. Af-1161 (free Base)

    17. 2-[3-[4-(3-chlorophenyl)piperazin-1-yl]propyl]-[1,2,4]triazolo[4,3-a]pyridin-3-one Hydrochloride

    18. 2-[3-[4-(3-chlorophenyl)piperazin-1-yl]propyl]-[1,2,4]triazolo[4,3-a]pyridin-3-one;hydrochloride

    19. Mls000069698

    20. Chebi:9655

    21. 1,2,4-triazolo[4,3-a]pyridin-3(2h)-one,2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-,hydrochloride (1:1)

    22. 2-(3-(4-(m-chlorophenyl)-1-piperazinyl)propyl)-s-triazolo(4,3-a)pyridin-3(2h)-one Monohydrochloride

    23. Trazodone Hydrochloride (desyrel)

    24. 1,2,4-triazolo(4,3-a)pyridin-3(2h)-one, 2-(3-(4-(3-chlorophenyl)-1-piperazinyl)propyl)-, Monohydrochloride

    25. Devidon

    26. Pragmazone

    27. Smr000058520

    28. Tombran

    29. Tritico

    30. Triticum

    31. Azona

    32. 25332-39-2 (hcl)

    33. Apo-trazodone

    34. Dsstox_cid_24626

    35. Dsstox_rid_80361

    36. Dsstox_gsid_44626

    37. 2-[3-[4-(3-chlorophenyl)piperazin-1-yl]propyl]-1,2,4-triazolo[4,3-a]pyridin-3(2h)-one Hydrochloride

    38. Desyrel Dividose

    39. 2-(3-(4-(3-chlorophenyl)piperazin-1-yl)propyl)-1,2,4-triazolo(4,3-a)pyridin-3(2h)-one Hydrochloride

    40. 2-{3-[4-(3-chlorophenyl)piperazin-1-yl]propyl}-2h,3h-[1,2,4]triazolo[4,3-a]pyridin-3-one Hydrochloride

    41. Sr-01000000190

    42. Ncgc00016035-02

    43. Einecs 246-855-5

    44. Unii-6e8zo8lrnm

    45. Cas-25332-39-2

    46. Nsc 292811

    47. Af 1161

    48. Trazodone, Hcl

    49. 2-[3-[4-(m-chlorophenyl)-1-piperazinyl]propyl]-s-triazolo[4,3-a]pyridin-3(2h)-one Monohydrochloride

    50. Prestwick_478

    51. Desyrel (tn)

    52. Einecs 243-216-2

    53. Trazodone Hydrochloride [usan:usp:jan]

    54. 2-[3-[4-(3-chlorophenyl)piperazin-1-yl]propyl]-[1,2,4]triazolo[4,5-a]pyridin-3-one

    55. Opera_id_850

    56. Schembl61754

    57. 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1,2,4-triazolo[4,3-a]pyridin-3(2h)-one Hydrochloride

    58. Mls000758230

    59. Mls001148260

    60. Mls001424009

    61. Spectrum1503121

    62. Chembl1200798

    63. Dtxsid8044626

    64. Hms1568l06

    65. Hms1922g09

    66. Pharmakon1600-01503121

    67. Trazodone Hydrochloride (jan/usp)

    68. Bcp04922

    69. Hy-b0478

    70. Tox21_110286

    71. Tox21_302685

    72. Tox21_501159

    73. Trazodone Hydrochloride [mi]

    74. Ccg-40299

    75. Nsc292811

    76. Nsc758393

    77. Trazodone Hydrochloride [jan]

    78. Trazodone Hydrochloride [hsdb]

    79. Trazodone Hydrochloride [usan]

    80. Akos015897762

    81. Tox21_110286_1

    82. Ac-6779

    83. Ks-5100

    84. Lp01159

    85. Nc00046

    86. Nsc-758393

    87. Trazodone Hydrochloride [mart.]

    88. Trazodone Hydrochloride [vandf]

    89. Trazodone Hydrochloride [usp-rs]

    90. Trazodone Hydrochloride [who-dd]

    91. Trazodone Hydrochloride Impurity Standard

    92. Ncgc00016035-13

    93. Ncgc00094420-01

    94. Ncgc00094420-02

    95. Ncgc00094420-03

    96. Ncgc00094420-04

    97. Ncgc00256807-01

    98. Ncgc00261844-01

    99. 2-(3-(4-(3-chlorophenyl)piperazin-1-y)propyl)-1,2,4-triazolo(4,3-a)pyridine-3(2h)-one Hydrochloride

    100. S-triazolo(4,3-a)pyridin-3(2h)-one, 2-(3-(4-(m-chlorophenyl)-1-piperazinyl)propyl)-, Monohydrochloride

    101. Eu-0101159

    102. Ft-0659024

    103. Ft-0675364

    104. S2582

    105. Trazodone Hydrochloride [orange Book]

    106. D00820

    107. D97808

    108. T 6154

    109. Trazodone Hydrochloride [usp Monograph]

    110. Trazodone Hydrochloride, >=99% (hplc), Powder

    111. 332t392

    112. A813950

    113. A817789

    114. A924854

    115. 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-

    116. J-015941

    117. Sr-01000000190-2

    118. Sr-01000000190-8

    119. Wln: T56 Anvnnj C3- At6n Dntj Dr Cg &gh

    120. Q27108459

    121. 1,2,4-triazolo[4,3-a]pyridin-3(2h)-one Hydrochloride

    122. Z1550675462

    123. Trazodone Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)

    124. Trazodone Hydrochloride, United States Pharmacopeia (usp) Reference Standard

    125. S-triazolo[4, 2-[3-[4-(m-chlorophenyl)-1-piperazinyl]propyl]-, Monohydrochloride

    126. S-trizolo[4, 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-, Hydrochloride

    127. 1,2,4-triazolo[4,3-a]pyridin-3(2h)-one, 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-, Hydrochloride (1:1)

    128. 1,4-triazolo[4,3-a]pyridin-3(2h)-one, 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-, Monohydrochloride

    129. 2-(3-(4-(3-chlorophenyl)piperazin-1-yl)propyl)-[1,2,4]triazolo[4,3-a]pyridin-3(2h)-onehydrochloride

    130. 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-[1,2,4]triazolo[4,3-a]pyridin-3-one Hydrochloride

    131. 2-[3-[4-(3-chlorophenyl)piperazin-1-yl]propyl]-[1,2,4]triazolo[4,3-a]pyridin-3-one;hydron;chloride

    132. 2-{3-[4-(3-chlorophenyl)piperazin-1-yl]propyl}[1,2,4]triazolo[4,3-a]pyridin-3(2h)-one Hydrochloride

    133. Trazodone Hydrochloride Solution, 1.0 Mg/ml In Methanol (as Free Base), Ampule Of 1 Ml, Certified Reference Material

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 408.3 g/mol
    Molecular Formula C19H23Cl2N5O
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count4
    Rotatable Bond Count5
    Exact Mass407.1279658 g/mol
    Monoisotopic Mass407.1279658 g/mol
    Topological Polar Surface Area42.4 Ų
    Heavy Atom Count27
    Formal Charge0
    Complexity611
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameOleptro
    PubMed HealthTrazodone (By mouth)
    Drug ClassesAntidepressant
    Drug LabelOleptro (trazodone hydrochloride) is a triazolopyridine. It is a white, odorless crystalline powder which is freely soluble in water.Chemical Name: 2-[3-[4-(m-Chlorophenyl)-1-piperazinyl]propyl]-s-triazolo[4,3-a]pyridin-3(2H)-one monohydrochloride St...
    Active IngredientTrazodone hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength150mg; 300mg
    Market StatusPrescription
    CompanyAngelini Pharma

    2 of 4  
    Drug NameTrazodone hydrochloride
    Drug LabelTrazodone HCl is an antidepressant chemically unrelated to tricyclic, tetracyclic, or other known antidepressant agents. Trazodone HCl is a triazolopyridine derivative designated as 2-[3-[4-(m-Chlorophenyl)-1-piperazinyl]propyl]s-triazolo[4,3-a]-pyri...
    Active IngredientTrazodone hydrochloride
    Dosage FormTablet
    RouteOral
    Strength150mg; 300mg; 100mg; 50mg
    Market StatusPrescription
    CompanyMylan Pharms; Apotex; Teva Pharms Usa; Torrent Pharms; Mutual Pharm; Vintage; Alvogen; Pliva

    3 of 4  
    Drug NameOleptro
    PubMed HealthTrazodone (By mouth)
    Drug ClassesAntidepressant
    Drug LabelOleptro (trazodone hydrochloride) is a triazolopyridine. It is a white, odorless crystalline powder which is freely soluble in water.Chemical Name: 2-[3-[4-(m-Chlorophenyl)-1-piperazinyl]propyl]-s-triazolo[4,3-a]pyridin-3(2H)-one monohydrochloride St...
    Active IngredientTrazodone hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength150mg; 300mg
    Market StatusPrescription
    CompanyAngelini Pharma

    4 of 4  
    Drug NameTrazodone hydrochloride
    Drug LabelTrazodone HCl is an antidepressant chemically unrelated to tricyclic, tetracyclic, or other known antidepressant agents. Trazodone HCl is a triazolopyridine derivative designated as 2-[3-[4-(m-Chlorophenyl)-1-piperazinyl]propyl]s-triazolo[4,3-a]-pyri...
    Active IngredientTrazodone hydrochloride
    Dosage FormTablet
    RouteOral
    Strength150mg; 300mg; 100mg; 50mg
    Market StatusPrescription
    CompanyMylan Pharms; Apotex; Teva Pharms Usa; Torrent Pharms; Mutual Pharm; Vintage; Alvogen; Pliva

    4.2 Drug Indication

    Treatment of insomnia

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Anti-Anxiety Agents

    Agents that alleviate ANXIETY, tension, and ANXIETY DISORDERS, promote sedation, and have a calming effect without affecting clarity of consciousness or neurologic conditions. ADRENERGIC BETA-ANTAGONISTS are commonly used in the symptomatic treatment of anxiety but are not included here. (See all compounds classified as Anti-Anxiety Agents.)

    Antidepressive Agents, Second-Generation

    A structurally and mechanistically diverse group of drugs that are not tricyclics or monoamine oxidase inhibitors. The most clinically important appear to act selectively on serotonergic systems, especially by inhibiting serotonin reuptake. (See all compounds classified as Antidepressive Agents, Second-Generation.)

    Selective Serotonin Reuptake Inhibitors

    Compounds that specifically inhibit the reuptake of serotonin in the brain. (See all compounds classified as Selective Serotonin Reuptake Inhibitors.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Serotonin Reuptake Inhibitor [EPC]

    API Reference Price

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AP.","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1642185000,"product":"RE-IMPORT TRAZODONE HYDROCHLORIDE (SB NO.2274668 DT.08.06.2021 INV NO.3522000082 DT.30.05.2021 & SB NO.9821435 DT.01.04.","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PAR KAMANI JUNCTION, LBS MARG,","city":"KURLA, MUMBAI","supplier":"LOTUS PHARMACEUTICAL CO LTD","supplierCountry":"INDIA","foreign_port":"#N\/A","customer":"PIRAMAL PHARMA LIMITED","customerCountry":"INDIA","quantity":"6011.57","actualQuantity":"6011.57","unit":"KGS","unitRateFc":"123.5","totalValueFC":"772648.4","currency":"USD","unitRateINR":"9574.4","date":"15-Jan-2022","totalValueINR":"57557243.06","totalValueInUsd":"772648.4","indian_port":"JNPT","hs_no":"29181990","bill_no":"7087896","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"#N\/A","supplierAddress":"","customerAddress":"PIRAMAL ANANTA, 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Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1649010600,"product":"PHARMACEUTICAL TRAZODONE HYDROCHLORIDE USP","address":"PLOT NO.2, MAITRIVIHAR BEHIND MAITRIVANAM, AMEERPET","city":"HYDERABAD","supplier":"AUROLIFE PHARMA LLC","supplierCountry":"UNITED STATES","foreign_port":"NA","customer":"AUROBINDO PHARMA LTD","customerCountry":"INDIA","quantity":"477.18","actualQuantity":"477.1792","unit":"KGS","unitRateFc":"168.4","totalValueFC":"81897.4","currency":"USD","unitRateINR":"12949.2","date":"04-Apr-2022","totalValueINR":"6179068.79","totalValueInUsd":"81897.4","indian_port":"HYDERABAD AIR","hs_no":"29335990","bill_no":"8138861","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PLOT NO.2, MAITRIVIHAR BEHIND MAITRIVANAM, AMEERPET"},{"dataSource":"API 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SPA","supplierCountry":"ITALY","foreign_port":"NA","customer":"AUROBINDO PHARMA LTD","customerCountry":"INDIA","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"380","totalValueFC":"1141.6","currency":"EURO","unitRateINR":"31312","date":"14-Oct-2022","totalValueINR":"93936","totalValueInUsd":"1141.6","indian_port":"HYDERABAD AIR","hs_no":"29335990","bill_no":"2884050","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PLOT NO.2, MAITRIVIHAR BEHIND MAITRIVANAM, AMEERPET"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1665772200,"product":"TRAZODONE HYDROCHLORIDE","address":"PLOT NO.2, MAITRIVIHAR BEHIND MAITRIVANAM, AMEERPET","city":"HYDERABAD","supplier":"ANGELINL PHARMA SPA","supplierCountry":"ITALY","foreign_port":"NA","customer":"AUROBINDO PHARMA 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AP.","supplier":"GOODMAN CHEMICALS CO LTD","supplierCountry":"INDIA","foreign_port":"LAEM CHABANG","customer":"MAITHILI LIFE SCIENCES PVT LTD","customerCountry":"INDIA","quantity":"250.00","actualQuantity":"250","unit":"KGS","unitRateFc":"91.5","totalValueFC":"27892.7","currency":"USD","unitRateINR":"9287.5","date":"25-Dec-2023","totalValueINR":"2321875.41","totalValueInUsd":"27892.7","indian_port":"Madras Sea","hs_no":"29335990","bill_no":"9399076","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"LAEM CHABANG","supplierAddress":"3 SOITIWANON 3 YEAK 9, TAMBON TALADKHWAN, AMPHUR MUANG NONTHABURI NONTHABURI 11000 Thailand","customerAddress":"PLOT NO.HIG-117, KPHB PHASE VI,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1705257000,"product":"TRAZODONE HYDROCHLORIDE USP(RE-IMPORT)S\/BILL NO. 9793934 DT.05.05.2023 BATCH NO. 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    11-Jan-2022
    25-Apr-2025
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    ABOUT THIS PAGE

    Looking for 25332-39-2 / Trazodone Hydrochloride API manufacturers, exporters & distributors?

    Trazodone Hydrochloride manufacturers, exporters & distributors 1

    87

    PharmaCompass offers a list of Trazodone Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Trazodone Hydrochloride manufacturer or Trazodone Hydrochloride supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Trazodone Hydrochloride manufacturer or Trazodone Hydrochloride supplier.

    PharmaCompass also assists you with knowing the Trazodone Hydrochloride API Price utilized in the formulation of products. Trazodone Hydrochloride API Price is not always fixed or binding as the Trazodone Hydrochloride Price is obtained through a variety of data sources. The Trazodone Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Trazodone Hydrochloride

    Synonyms

    25332-39-2, Trazodone hcl, Desyrel, Bimaran, Molipaxin, Thombran

    Cas Number

    25332-39-2

    Unique Ingredient Identifier (UNII)

    6E8ZO8LRNM

    About Trazodone Hydrochloride

    A serotonin uptake inhibitor that is used as an antidepressive agent. It has been shown to be effective in patients with major depressive disorders and other subsets of depressive disorders. It is generally more useful in depressive disorders associated with insomnia and anxiety. This drug does not aggravate psychotic symptoms in patients with schizophrenia or schizoaffective disorders. (From AMA Drug Evaluations Annual, 1994, p309)

    Deprax Manufacturers

    A Deprax manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Deprax, including repackagers and relabelers. The FDA regulates Deprax manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Deprax API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of Deprax manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Deprax Suppliers

    A Deprax supplier is an individual or a company that provides Deprax active pharmaceutical ingredient (API) or Deprax finished formulations upon request. The Deprax suppliers may include Deprax API manufacturers, exporters, distributors and traders.

    click here to find a list of Deprax suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Deprax USDMF

    A Deprax DMF (Drug Master File) is a document detailing the whole manufacturing process of Deprax active pharmaceutical ingredient (API) in detail. Different forms of Deprax DMFs exist exist since differing nations have different regulations, such as Deprax USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Deprax DMF submitted to regulatory agencies in the US is known as a USDMF. Deprax USDMF includes data on Deprax's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Deprax USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Deprax suppliers with USDMF on PharmaCompass.

    Deprax JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Deprax Drug Master File in Japan (Deprax JDMF) empowers Deprax API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Deprax JDMF during the approval evaluation for pharmaceutical products. At the time of Deprax JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Deprax suppliers with JDMF on PharmaCompass.

    Deprax KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Deprax Drug Master File in Korea (Deprax KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Deprax. The MFDS reviews the Deprax KDMF as part of the drug registration process and uses the information provided in the Deprax KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Deprax KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Deprax API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Deprax suppliers with KDMF on PharmaCompass.

    Deprax CEP

    A Deprax CEP of the European Pharmacopoeia monograph is often referred to as a Deprax Certificate of Suitability (COS). The purpose of a Deprax CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Deprax EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Deprax to their clients by showing that a Deprax CEP has been issued for it. The manufacturer submits a Deprax CEP (COS) as part of the market authorization procedure, and it takes on the role of a Deprax CEP holder for the record. Additionally, the data presented in the Deprax CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Deprax DMF.

    A Deprax CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Deprax CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of Deprax suppliers with CEP (COS) on PharmaCompass.

    Deprax WC

    A Deprax written confirmation (Deprax WC) is an official document issued by a regulatory agency to a Deprax manufacturer, verifying that the manufacturing facility of a Deprax active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Deprax APIs or Deprax finished pharmaceutical products to another nation, regulatory agencies frequently require a Deprax WC (written confirmation) as part of the regulatory process.

    click here to find a list of Deprax suppliers with Written Confirmation (WC) on PharmaCompass.

    Deprax NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Deprax as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Deprax API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Deprax as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Deprax and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Deprax NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Deprax suppliers with NDC on PharmaCompass.

    Deprax GMP

    Deprax Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of Deprax GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Deprax GMP manufacturer or Deprax GMP API supplier for your needs.

    Deprax CoA

    A Deprax CoA (Certificate of Analysis) is a formal document that attests to Deprax's compliance with Deprax specifications and serves as a tool for batch-level quality control.

    Deprax CoA mostly includes findings from lab analyses of a specific batch. For each Deprax CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    Deprax may be tested according to a variety of international standards, such as European Pharmacopoeia (Deprax EP), Deprax JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Deprax USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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